Surgery: splint – brace – or bandage – Bandage structure – Retainers for wound dressings
Reexamination Certificate
1999-06-28
2001-03-20
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
Retainers for wound dressings
C602S057000, C602S058000
Reexamination Certificate
active
06203512
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to methods for opening individual packages and retrieving absorbent interlabial devices therein that are worn interlabially by female wearers for catamenial purposes, incontinence protection, or both.
BACKGROUND OF THE INVENTION
All manner and variety of absorbent articles configured for the absorption of body fluids such as menses, urine and feces are, of course, well known. With respect to feminine protection devices, the art has offered two basic types; sanitary napkins have been developed for external wear about the pudendal region while tampons have been developed for internal wear within the vaginal cavity for interruption of menstrual flow therefrom. Such tampon devices are disclosed in U.S. Pat. No. 4,412,833, entitled “Tampon Applicator,” issued to Weigner, et al. on Nov. 1, 1983, and U.S. Pat. No. 4,413,986, entitled “Tampon Assembly With Means For Sterile Insertion”, issued to Jacobs on Nov. 8, 1983.
Hybrid devices that attempt to merge the structural features of the sanitary napkins and the tampons into a single device have also been proposed. Such hybrid devices are disclosed in U.S. Pat. No. 2,092,346, entitled “Catamenial Pad,” issued to Arone on Sep. 7, 1937, and U.S. Pat. No. 3,905,372, entitled “Feminine Hygiene Protective Shield,” issued to Denkinger on Sep. 16, 1975. Other less intrusive hybrid devices are known as labial or interlabial sanitary napkins and are characterized by having a portion which at least partially resides within the wearer's vestibule and a portion which at least partially resides external of the wearer's vestibule. Such devices are disclosed in U.S. Pat. No. 2,662,527, entitled “Sanitary Pad,” issued to Jacks on Dec. 15, 1953, and U.S. Pat. No. 4,631,062, entitled “Labial Sanitary Pad,” issued to Lassen, et al. on Dec. 23, 1986.
Interlabial pads have the potential to provide even greater freedom from inconvenience because of their small size and reduced risk of leakage. Numerous attempts have been made in the past to produce an interlabial pad which would combine the best features of tampons and sanitary napkins while avoiding at least some of the disadvantages associated with each of these types of devices. Examples of such devices are described in U.S. Pat. No. 2,917,049 issued to Delaney on Dec. 15, 1959, U.S. Pat. No. 3,420,235 issued to Harmon on Jan. 7, 1969, and U.S. Pat. No. 4,595,392 issued to Johnson, et al. on Jun. 17, 1986. A commercially available interlabial device is FRESH 'N FIT® PADETTE® interlabial product that is marketed by Athena Medical Corp. of Portland, Oreg. and described in U.S. Pat. Nos. 3,983,873 and 4,175,561 issued to Hirschman on Oct. 5, 1976 and Nov. 27, 1979, respectively.
Absorbent interlabial articles need to be hygienically stored from the time of their manufacture until the article is used. This is a particular concern with respect to maintaining a sanitary environment prior to placement or insertion. That is, a need exists to hygienically store an individual absorbent article while being transported to prevent transferring unsanitary particles to the pudendal or vaginal area.
The packaging for the commercially available FRESH 'N FIT® PADETTE® interlabial product is made from a coated paper sheet that is wrapped around the product and sealed on the transverse ends and along the longitudinal edges. The transverse ends and longitudinal edges of the product are sometimes sealed with an adhesive and are then crimped or knurled together. An example of packaging for an interlabial pad is shown in U.S. Pat. No. 4,743,245 entitled “Labial Sanitary Pad” that issued to F. O. Lassen, et al. on May 10, 1988. However, there are drawbacks to these interlabial product packages.
One important drawback is that packages for interlabial products do not provide a means for users of interlabial products to preserve hygiene when removing a product from a protective package or inserting an interlabial product into the folds of the skin. The lack of hygiene in restrooms, the need to touch the doors of non-hygienic restrooms, and the necessity to touch themselves while inserting the device may result in the possibility of infection. In addition, when inserting the device during menstruation, it is desirable to keep the user's hands free from soiling. Therefore, the consumer needs an individual package that will hygienically protect an interlabial device during its removal from a package and simultaneously during insertion thereof.
Other packages for sanitary articles are described in U.S. Pat. No. 3,062,371 entitled “Internally Sterile Composite Package” that issued to D. Patience on Nov. 6, 1962 and U.S. Pat. No. 3,698,549 entitled “Packages for Small Articles” that issued to J. A. Glassman on Oct. 17, 1972. The Patience patent describes a package that is opened by folding back a panel from the package and removing its content by using sterile forceps. The Glassman patent describes a package that has internal pockets for holding flat articles such as gauze dressings or surgical sponges. The package is opened and exposes separate pockets for removal of individual articles.
Although the packages described in the Patience patent, the Glassman patent, the package used with the PADETTE® product, and the package described in the Lassen patent protect the enclosed article, the package does not aid in the hygienic removal, insertion and placement of the absorbent interlabial device or provide a barrier to prevent the wearer's hand from touching the product or the wearer's body. Additionally, neither package described above provides a convenient means for users of interlabial products to dispose of the packaging after the product has been used. Conventionally, users would dispose of the packaging by placing the product in her purse, throwing it on the bathroom floor, placing it in a trash receptacle for sanitary products, or placing the packaging in a trash receptacle outside of the bathroom stall. Some users may attempt to flush packages whether they are or are not designed to be flushed, and regardless of whether they are dispersible in water or biodegradable.
Packages for tampons are described in U.S. Pat. No. 3,135,262 entitled “Tampon” that, issued to W. Kobler, et al. on Jun. 2, 1964 and U.S. Pat. No. 5,180,059 entitled “Package of a Sanitary Tampon” that issued to S. Shimatani and K. Shimatani on Jan. 19, 1993. The Kobler patent describes a package that when unwrapped, forms what Kobler describes as an umbrella to cover the user's hands. Because of the shape of the tampon (the height of the tampon is considerably greater than the tampon's longitudinal dimension), the package must be considerably longer than the tampon to encircle the user's hand when opened. When the package is opened, the material that forms the shield is large and would be an impediment to proper placement. Additionally, the package in the Kobler patent does not completely seal all parts of the product inside the package creating the potential for contamination. Specifically, the tear cord used to break the band that holds the package onto the tampon must be touched by the user. The same cord, when the tampon is in use, then resides in the vaginal region that is sensitive to contamination.
The Shimatani patent describes a package that comprises packing sheets superimposed on another to enclose the tampon to create a shield when inserting the tampon. This patent fails to provide a sterile environment because it, too, does not seal all parts of the product inside the package that should be protected from contamination or prevent the user from touching parts that should maintain sterility. Additionally, the stiffness of the Shimatani package would not provide comfort for the user when inserting the article.
The packages for the Kobler and Shimatani patents are tall and circular in shape. The Kobler and Shimatani packages may be suitable in packaging articles that have a height greater than its longitudinal dimension, however, with smaller articles such as an inte
Farris Diane Dunn
Hall Alicia Mary
Osborn III Thomas Ward
Brown Michael A.
Cummings Theodore P.
Fitzpatrick Matthew P.
Hamilton Lalita M.
Johnson Kevin C.
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